Ziyaad Patel

As a dedicated Clinical Trial Associate with a degree in Biomedical Science, I am eager to enhance my skill set role in Clinical Operations, leveraging my expertise as a clinical trial associate or project associate. With a strong foundation in study protocols, standard operating procedures, and trial oversight, I am committed to driving process improvements and ensuring compliance in clinical research. In my current role, I have developed extensive experience in Veeva Vault, utilizing the system to maintain essential trial documentation, support audit readiness, and streamline workflows for study teams.

I have successfully managed to assist document submissions, version control, and TMF maintenance within Veeva Vault, ensuring seamless collaboration between stakeholders. Additionally, I have leveraged Veeva reports and dashboards to track study progress, identify bottlenecks, and enhance productivity across teams. My experience extends to supporting major pharmaceutical studies.

I have completed specialized study training and worked within multiple clinical systems such as CTMS, Pfizer systems, and GOBALTO, allowing me to provide both administrative and technical support to project teams. My proactive approach to system optimization and my ability to extract actionable insights from Veeva Vault reports have contributed to improved trial efficiency and compliance. I am a hardworking, detail-oriented professional with a passion for clinical research and operational excellence.

I thrive in dynamic environments where I can apply my technical expertise and problem-solving skills to enhance trial management processes. I am eager to bring my knowledge of Veeva Vault and clinical operations to a consultancy role, where I can support teams in maximizing system capabilities, improving audit readiness, and driving overall study success

Clinical Trial Associate II - Ora Clinical

(2023-10)

• Ensure study documentation, communication, training, and data collection align with protocols, SOPs, regulations, and guidelines.
• Lead development of study documents (e.g., informed consent, source documents, study logs).
• Manage all phases of site operations from start-up to closeout.
• Collect and review site regulatory documents (e.g., 1572, Financial Disclosures, CLIA waivers).
• Prepare essential documents for investigational product release and regulatory submissions.
• Create and submit regulatory packages for IRB/IEC approval and study/site continuity.
• Assemble and distribute regulatory binders; maintain Investigator Site File tracker.
• Support project management with meeting minutes, agendas, newsletters, and study tracking.
• Assist in study reporting, site status updates, and metrics collection.
• Set up, maintain, and QC Trial Master File (TMF/eTMF) and file-sharing platforms.
• Participate in study planning, risk assessment, and pre-study meetings.
• Support process improvements, SOP reviews, and departmental training.
• Assist with audit preparations and responses to findings.
• Extract Veeva reports and feedback to the team
• Lead TMF related meetings
• Provide metrics monthly to the project director
• Supporting CRAs in visit preparation and filing
• Supporting CTMs/PMs in country project related expenditures
• Assisting in translation and translation QC
• Distribute country and site level communications
• Creating and maintain investigator list
• QC of country and site-level documents
• Submission of complete country and site-level documents to eTMF and related tracking in CTMS
• Performing document tracking in CTMS, verifies appropriate country or site level activity plans are applied, updates country level activities/documents for amendments.
• Provide support to other CTA's during onboarding, providing them trainings.
• Upload, organize, and maintain essential trial documents in Veeva Vault eTMF (electronic Trial Master File).
• Ensure all documents comply with ICH-GCP, SOPs, and regulatory requirements.
• Perform quality control (QC) reviews of uploaded documents to ensure accuracy and completeness.
• Track document versioning and approvals to maintain audit readiness.
• Assist with study start-up, conduct, and closeout by managing site regulatory documents in Veeva Vault.
• Maintain site documentation such as 1572 forms, Financial Disclosures, IRB approvals, and site contracts.
• Generate and track Investigator Site Files (ISF) and ensure proper distribution of essential documents.
• Monitor and update study workflows in Veeva Vault to streamline processes.
• Generate study reports and dashboards to track compliance, document completeness, and site progress.
• Provide training and technical support to study teams on best practices for using Veeva Vault.
• Conduct regular TMF/eTMF audits to ensure completeness and compliance.
• Support internal and external audits by retrieving and organizing documents in Veeva Vault.
• Identify process gaps and contribute to system optimizations and efficiency improvements

Clinical Operations Specialist - Syneos Health FSP

(2023-07 - 2023-08)

• Ensure compliance with Corporate and Clinical Operations policies, SOPs, and work instructions.
• Support site management, acting as a Sponsor representative and ensuring protocol adherence.
• Maintain and audit the Trial Master File (TMF) and project files.
• Prepare and update site manuals, reference tools, and study documents.
• Input and manage clinical tracking data in databases.
• Track and update clinical and regulatory documents for investigator sites and project teams.
• Manage shared mailbox, process site requests, and route correspondence.
• Coordinate ordering, shipping, and tracking of site supplies.
• Organize team meetings, attend sessions, and document meeting minutes and action items.
• Handle receipt, tracking, and disposition of Case Report Forms and Queries.

Site Activation Coordinator - PPD in Partnership with Thermo Fisher Scientific

(2021-10 - 2023-06)

• Performing department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system
• Ensuring allocated tasks are performed on time, within budget and to a high-quality standard
• Proactively communicating any risks to project leads
• Supporting the maintenance of study specific documentation and systems including but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate system
• Providing system support (i.e. GoBalto & eTMF)
• Supporting RBM activities
• Performing administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members
• Supporting scheduling of client and/or internal meetings
• Reviewing and tracks local regulatory documents
• Analyzing and reconciles study metrics and findings reports
• Assisting with clarification and resolution of findings related to site documentation
• Maintains vendor trackers
• Assisting with coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites
• Assisting with study-specific translation materials and translation QC upon request
• Providing administrative support for site-initiated amendments and site supply shipments
• Managing couriers
• Supporting CRAs in visit preparation and filing
• Supporting CTMs/PMs in country project related expenditures
• Assisting in translation and translation QC
• Distribute country and site level communications
• Creating and maintain investigator list
• QC of country and site-level documents
• Submission of complete country and site-level documents to eTMF and related tracking in CTMS
• Performing document tracking in CTMS, verifies appropriate country or site level activity plans are applied, updates country level activities/documents for amendments
• Compiling and distributing Investigator Site File (ISF) and Pharmacy binder to site prior to SIV
• Reviewing eTMF reports and Preclarus dashboards to identify country and site level essential documents statuses
• Following up on outstanding/missing study documents to be sent to site.
• Forward "wet ink" documents retrieved from sites
• Applying updated site level activity plans, including push down of study documents from country to site level
• Periodic Safety Reporting for Urgent Safety Measures Notifications
• Liaising with sites regarding important study activities, including but not limited to: Investigator meeting attendance and transport, IP and Lab supplies and orders, Communications including phone calls to sites regarding new participants, lab supplies, and study closeouts
• Tracking and filing ePIP reports
• Completing Source Data Agreement Forms
• Updating CTMS and milestones on Activate
• Requesting EDC Access and vendor access for sites

First class Hons - Biomedical Science - University of Greenwich (2018 - 2021)

A Levels - Stoke Newington School & Sixth form (2016 - 2018)

GCSEs - Stoke Newington School & Sixth form (2011 - 2018)